Frequently asked questions about reporting adverse drug reactions (ADRs)

You shall not submit the downloaded report again to the EudraVigilance database. This would create a duplicate and cause extra work for EMA and the national competent authority.

22 Sep 2020, updated 19 Nov 2024

The report shall not be submitted to the MAHs B+C. After you have submitted the report to the EudraVigilance database the MAHs B+C will identify there the report concerning their own product and enter it into their own databases. MAHs B+C shall not submit the downloaded report again to the EudraVigilance database.

24 Jan 2018, updated 19 Nov 2024

In the reports submitted by Fimea, the E2B(R3) fields mainly appear in English in their text form. The exceptions are the descriptions of the ADRs as reported in the primary source's language (”E.i.1.1a Reaction / event as reported by the primary source in native language”) and the narrative (”H.1 Case narrative including clinical course, therapeutic measures, outcome and additional relevant information”) which is submitted to the EudraVigilance database in the language in which it was reported to Fimea (Finnish, Swedish, English).

In addition to the E2B(R3) fields E.i.1.1a and H.1, the reports submitted by Fimea might, along with the possible English translation, include text in the primary source's language also in other E2B(R3) fields allowing free text.

24 Jan 2018, updated 19 Nov 2024

Instructions can be found in the Guideline on good pharmacovigilance practices (GVP) Module VI (EMA, HMA, pdf) in the section ”VI.C.6.2.2.11. Handling of languages”. Unless otherwise requested by competent authorities, the reports shall be submitted in English to the EudraVigilance database.

Fimea encourages MAHs to submit the information on the medication and the reported ADR terms to the EudraVigilance database in as much detail as possible, including the ADRs as reported in the primary source's language in the E2B(R3) fields ”E.i.1.1a Reaction / event as reported by the primary source in native language”.

19 Nov 2024

The access rights of the MAHs are described in the document European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use (EudraVigilance Access Policy) (pdf). The answer to this question can be found in ”Annex C - Confidentiality Undertaking for marketing authorisation holders: Access to the ICSR data set Level 2B under the policy”.

24 Jan 2018, updated 19 Nov 2024

Articles need not be sent to Fimea. If necessary, Fimea will request the article.

24 Jan 2018, updated 19 Nov 2024

In order to confirm a report as a duplicate, the MAH may, if necessary, contact Fimea ([email protected]). Likewise, Fimea may contact the MAH if it suspects the existence of a duplicate.

If the report is confirmed as a duplicate, it will be agreed between the parties which one will report the duplicate to EMA (EMA Service Desk (ServiceNow)) and EMA will create a master case to the EudraVigilance database.

22 Sep 2020, updated 19 Nov 2024

In such situations, the MAH should contact Fimea ([email protected]), if necessary, and the procedure will be agreed with Fimea on a case-by-case basis.

However, the procedure regarding follow-up information requests is as described in the Guideline on good pharmacovigilance practices (GVP) Module VI (EMA, HMA, pdf) in chapter ”VI.C.2.2. Responsibilities of the marketing authorisation holder in the EU”:
“For the ICSRs made accessible to a marketing authorisation holder from the EudraVigilance database in accordance with Article 24(2) of Regulation (EC) No 726/2004 and in line with the EudraVigilance Access Policy for Medicines for Human Use24, the routine request for follow-up by the marketing authorisation holder is not foreseen. If the follow-up of an ICSR is necessary for a specific situation, a justification should be provided with the request, which should be addressed directly to the sender organisation of the ICSR.”

Before submitting a report to the EudraVigilance database, Fimea will assess the need for follow-up information request for each report and contacts the reporter if needed. Hence, the MAH shall not routinely ask for follow-up information via Fimea. In situations listed below no follow-up information is routinely requested from the reporter, unless assessed necessary:

• information has already been requested on the initial reporting form (for example symptoms and/or diagnosis, test results, and medical history)
• medical confirmation for consumer reports
• information is presumably not available to the reporter (for example detailed test results for a case reported by a pharmacist)

22 Sep 2020, updated 19 Nov 2024

In such situations, the MAH should contact Fimea ([email protected]), if necessary, and the procedure will be agreed with Fimea on a case-by-case basis.

Before submitting a report to the EudraVigilance database, Fimea will assess the need for follow-up information request for each report and contacts the reporter if needed. Hence, the MAH shall not routinely ask for follow-up information via Fimea. In situations listed below no follow-up information is routinely requested from the reporter, unless assessed necessary:

• information has already been requested on the initial reporting form (for example symptoms and/or diagnosis, test results, and medical history)
• medical confirmation for consumer reports
• information is presumably not available to the reporter (for example detailed test results for a case reported by a pharmacist)

30 Sep 2020, updated 19 Nov 2024

The details provided on an ADR report are confidential. They include personal data on the patient and the reporter. The disclosure of information and content of the report are based on the Medicines Act (395/1987).

According to subsection 2 of section 30 e (1258/2021) of the Medicines Act (395/1987), the marketing authorisation holder, parallel import authorisation holder and registration holder shall, as a guarantee of pharmacovigilance and patient safety on the part of the register holder, record in the ADR database all the necessary details concerning both identified and suspected ADRs, essential details concerning the medical conditions of the user of the medicine or person’s propensity for them, all medications, their therapeutic indications and ADRs, and for person identification, if available, the name, personal ID, age and gender of the user of the medicine. According to section 30 f (1258/2021) of the Medicines Act (395/1987), the information concerning the ADRs shall be reported to the EudraVigilance database.

There are no EU provisions on the precise content of an ADR report. National provisions therefore apply. Section 30 e (1258/2021) of the Medicines Act (395/1987) does not lay down any restrictions as regards the disclosure of information identifying the patient or the reporter. There are no restrictions either in the other provisions of the Medicines Act concerning ADR reporting.

Fimea considers that subsection 2 of section 30 f (1258/2021) of the Medicines Act (395/1987) should be interpreted in accordance with Regulation (EU) 2016/679 (General Data Protection Regulation) of the European Parliament and Council and the data protection principles set out in the Commission Implementing Regulation (EU) 520/2012 on the performance of pharmacovigilance activities. In Fimea's view, this means that MAHs may be allowed to restrict certain parts of the personal data submitted to the EudraVigilance database (post-authorisation module, EVPM) with regard to the provision of the Medicines Act mentioned above. Neverthelss, MAHs must retain full information in their ADR databases according to section 30 e (1258/2021) of the Medicines Act (395/1987) so that the competent authority always has a possibility to receive further information on an ADR report and a person who has experienced the suspected ADR for a case assessment or for example for duplicate detection.

Based on the above, Fimea considers that MAHs do not need to submit all personal data of a patient to the EudraVigilance database (EVPM). Instead, MAHs must submit such part of the following information on a case-by-case basis, that it is still possible to identify any overlapping/duplicate reports: date of birth, gender, age, age group, initials, name.

If Fimea later finds that the instructions described here hinder pharmacovigilance and the processing of ADR reports excessively, the instructions will be updated if necessary.

Fimea has no special requirements for the reporter's information to be submitted to the EudraVigilance database (EVPM) but the Guideline on good pharmacovigilance practices (GVP) Module VI (EMA, HMA, pdf) should be followed.

24 Jan 2018, updated 19 Nov 2024

Regarding literature monitoring in Finland, the instructions of the Guideline on good pharmacovigilance practices (GVP) Module VI (EMA, HMA, pdf) should be followed, e.g. sections:

• VI.B.1.1.2. Literature reports
• VI.C.2.2.3. Case reports published in the medical literature
• VI.C.2.2.3.1 Monitoring of the medical literature by the European Medicines Agency
• VI.C.2.2.3.2 Exclusion criteria for the submission of ICSRs published in the medical literature
• VI. Appendix 2 Detailed guidance on the monitoring of the medical literature

Fimea does not have an official list of journals, databases or websites to be monitored. Therefore, each MAH has to decide which sources to monitor, based on one’s own product range. However, in practice in Finland, each MAH should monitor at least the journals Lääkärilehti and Aikakauskirja Duodecim, based on the GVP Module VI instructions.

EMA monitors selected medical literature for suspected ADRs to certain active substances and is responsible for reporting these ADRs to the EudraVigilance database. MAHs shall report to the EudraVigilance database only the suspected ADRs found in the medical literature monitoring they are responsible for. More information can be found on the website Medical literature monitoring (EMA). Any further questions on EMA’s literature monitoring should be directed to EMA (Medical Literature Monitoring Service Desk).

19 Nov 2024

Fimea does not have any special requirements for these reports. In Finland, these reports are handled as spontaneous reports following the instructions of the Guideline on good pharmacovigilance practices (GVP) Module VI (EMA, HMA, pdf):

”VI.C.1.2.2. Compassionate use and named patient use

…for compassionate use and named patient use conducted in Member States (or in countries outside the EU) where the active collection of adverse events occurring in these programmes is not required, any notified noxious or unintended response to the supplied medicinal product should be submitted as ICSR in accordance with the time frames and modalities provided in VI.C.3. and VI.C.4.. It should be considered as a spontaneous report of suspected adverse reaction (see VI.6.2.3.7 Subsection 2 for guidance on the electronic submission of these ICSRs).”

19 Nov 2024

Fimea does not have any special requirements for these reports. In Finland, these reports are handled as spontaneous reports following the instructions of the Guideline on good pharmacovigilance practices (GVP) Module VI (EMA, HMA, pdf).

19 Nov 2024